FDA Devices recall · Reported July 5, 2017
SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and C02, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output.
Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in patient care.
Merge Healthcare, Inc. recalled SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014), Produ… - a moderate-severity action.
SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014), Produ… was recalled by Merge Healthcare, Inc. in July 5, 2017. Reason: Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displayi…. Check the official notice for the remedy. Verify recall #Z-2640-2017 with the FDA Devices before acting.
The recall
Merge Healthcare, Inc. issued this moderate-severity FDA Devices recall-Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displayi….
- Moderate
- severity level
- Class II
- classification
- July 5, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2640-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and C02, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output.
Reason for recall
Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in patient care.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2640-2017 |
| Date reported | July 5, 2017 |
| Date initiated | April 4, 2016 |
| Recalling firm | Merge Healthcare, Inc. |
| Firm location | Hartland, WI |
| Affected scope | 219 cables |
| Distribution | Distribution was nationwide. There was also government and military distribution. There was no foreign distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2640-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Why was this product recalled? ▼
Which agency issued this recall? ▼
Where was the recalled product distributed? ▼
Should I stop using a recalled medication or medical device? ▼
Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
Compare this recall with GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VS… → · All Medical Devices recalls
Methodology · Corrections · Archive as of August 2026